Protocol Administration Set with Small Catheter and Retention Cuff 390402

GUDID 30815112021284

Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon Insufflation

BRACCO DIAGNOSTICS INC

Insufflation gas conditioning tubing set

• Primary Device ID: 30815112021284
• NIH Device Record Key: 3993f4cd-4f02-47d1-8d14-53ee9d541862
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protocol Administration Set with Small Catheter and Retention Cuff
• Version Model Number: 390402
• Catalog Number: 390402
• Company DUNS: 849234661
• Company Name: BRACCO DIAGNOSTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx

Device Dimensions

• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815112021280 [Primary]
GS1	30815112021284 [Package]; Contains: 10815112021280; Package: Box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030854

FDA Product Code

• FCX: Insufflator, Automatic Carbon-Dioxide For Endoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-07
• Device Publish Date: 2023-06-29

On-Brand Devices [Protocol Administration Set with Small Catheter and Retention Cuff]

• 30815112020171: Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon
• 30815112021284: Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon